Identifiers
- 510(k) Number
- K232172 FDA 510(k)
- FDA Product Code
- NFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BTL-785BNF Handpiece is a transcutaneous electrical stimulator intended for aesthetic purposes. It is used for electrostimulation therapy on facial, neck, and body skin.
The device is supplied as part of a system with a main control unit and touch screen interface. It is FDA 510(k) cleared with product code NFO and is substantially equivalent to previously cleared devices.
Frequently asked questions
What is the BTL-785BNF Handpiece used for?
The BTL-785BNF Handpiece is a transcutaneous electrical stimulator intended for aesthetic purposes. It is used for electrostimulation therapy on facial, neck, and body skin as part of a system with a main control unit and touch screen interface.
Is the BTL-785BNF Handpiece single-use or reusable?
The device data does not specify whether the BTL-785BNF Handpiece is single-use or reusable. This information would typically be found in the device's instructions for use or product specifications.
What regulatory approvals does the BTL-785BNF Handpiece have?
The BTL-785BNF Handpiece is FDA 510(k) cleared with product code NFO and is substantially equivalent to previously cleared devices. It was received by the FDA on 2023-07-21 and cleared on 2023-09-18.
What sizes or models of the BTL-785BNF Handpiece are available?
The device data does not specify different sizes or models of the BTL-785BNF Handpiece. The information provided only mentions the single device name and model number.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BTL-785BNF Handpiece: FDA Clearance & Evidence Check | SkinCarisma, PDF September 18, 2023 David Chmel 362 Elm Street Trade/Device Name: BTL ..., K232172 FDA 510(k) - BTL-785BNF Handpiece | BTL Industries, Inc., BTL-785BNF Handpiece (K232172) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232172 | Class II | Active |
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Manufacturer
- Manufacturer
- BTL Industries, Inc.
Sources (1)
- FDA 510(k) K232172 24 fields · synced Sep 24, 2026